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Trial Title:
Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries
NCT ID:
NCT05546021
Condition:
Anesthesia; Adverse Effect
Breast Cancer
Conditions: Keywords:
nociception level monitor
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
NOL monitor
Description:
NOL technology uses a multiparameter-based sensor platform, and advanced algorithm, to
continuous monitor Autonomic Nervous System (ANS) functions. NOL reflects a patient's
nociceptive state and analgesic effect, helping to optimize the administration of
systemic and/or regional analgesics and avoiding overdose or underuse of these drugs.
The nociception level is a multiparameter monitor that combines information from the
finger photoplethysmogram amplitude, skin conductance, skin conductance fluctuation,
heart rate, heart rate variability, and their time derivatives into one index ranging
from 0 (absence of noxious stimulation) to 100 (severe noxious stimulation). The
nociception level is a composite score derived from a set of physiologic variables (i.e.,
peripheral effectors of the autonomous nervous system): heart rate, heart rate
variability, the amplitude of the photoplethysmogram, skin conductance, skin conductance
variability, and the time derivatives of these variables.
Arm group label:
NOL monitor
Summary:
To assess if perioperative consumption of opioids can be optimized with the assistance of
a Nociception Level (NOL) monitor in breast surgery patients receiving pectoral and
parasternal nerve blocks as supplementation to general anaesthesia.
Hypothesis:
1. NOL monitor guidance optimizes perioperative analgesic consumption and postoperative
length of stay and offers a better quality of recovery in breast surgery.
2. Intraoperative NOL monitoring can detect the efficacy of pectoralis and parasternal
nerve blocks.
3. Incidence of persistent neuropathic pain after breast cancer surgery is lower in
patients receiving lower doses of perioperative opioids.
Detailed description:
Optimal perioperative pain management is important not only for patient satisfaction but
also for hemodynamic stability and effective restitution. Despite being the principal
element of anaesthesia, analgesia delivery has long been based on non-objective surrogate
parameters such as blood pressure and heart rate. This may lead to hemodynamic
inconsistency, poor restitution and patient dissatisfaction, which are some of the
observed challenges. In that context, there has long been a search for a monitor which
can guide the meticulous administration of analgesics. Recently, a nociception level
monitor (NOL) based on an advanced software algorithm was developed using multiple
physiological parameters. It offers an objective number (NOL Index) which relates to the
level of intra-operative pain. NOL technology has been validated and found superior to
existing pain indicators in peer-reviewed publications. With the availability of NOL
monitors, a meticulous adjustment in the administration of opioids became a possibility.
Therefore, the investigators are planning a randomised study to investigate if opioid
consumption can be reduced and if immediate and long-term postoperative complications can
be minimised.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- American Society of Anaesthesiologists (ASA) class I-IV patients scheduled for an
elective mastectomy with or without axillary resection
Exclusion Criteria:
- Inability to give consent,
- atrial fibrillation,
- local anesthetic allergy,
- lumpectomy converted to Mastectomy.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sygehus Soenderjylland
Address:
City:
Aabenraa
Zip:
6200
Country:
Denmark
Start date:
September 1, 2023
Completion date:
March 2025
Lead sponsor:
Agency:
University of Southern Denmark
Agency class:
Other
Source:
University of Southern Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05546021
